Thoracolumbar Interfascial Plane Block in Vertebral Surgery

Completed

• Conditions: Block

• Registration Number: NCT04548076
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

To determine the postoperative analgesic efficiency of thoracolumbar interfascial plane block , patients are divided into two groups. Study group received ultrasound-guided thoracolumbar interfascial plane block , where control had none. Visual analog scale and opioid consumption are recorded.

Detailed Description

Thoracolumbar interfascial plane block has successfully been demonstrated to provide an efficient analgesia in patients. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of thoracolumbar interfascial plane block in patients with vertebral surgery. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS\>4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS\>4 the same dose will be repeated. A patient satisfaction questionnaire (Qr40)will be filled by patients at the postoperative 24th hour.

Study Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Primary Completion: 2021-08-21
• Study Completion: 2021-11-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Over 18 years of age, Planned to vertebral surgery, An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria

Severe cardiovascular disease, Psychiatric diseases, Rejected to participation, Those who have chronic pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale	one time in postoperative period for one year	Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	During postoperative period for one yea	Opioid consumption

Trial Locations

Locations (1)

Gaziosmanpasa University; 🇹🇷 Tokat, Turkey